Protocol summary

Study aim
Determining the Effect of Interface Nurse on Family Satisfaction and Physiological Indicators of Transition Patients from the Intensive Care Unit
Design
A randomized clinical trial of two groups, which will be performed on 90 patients.
Settings and conduct
The present study will be carried out in Besat Hospital of Hamadan. In this study, after the transfer order to the general ward by physician, the nurse will start the research and continue for at least 2 hours after the patient is deployed in thegeneral ward. First, he communicates with the patient and his family, informing the patient about the transfer to the generalward, then introduces himself as the nurse of the patient. The patient in the intervention group will receive nursing services in addition to routine care. The intervention group will be visited daily by the Nurse twice a day for 3 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of patients between (18-65) years, Patients admitted to the intensive care unit who have been admitted for at least 72 hours, According to the doctor's instructions, the patient should be transferred from the intensive care unit to the general public. exclusion criteria: Sudden hemodynamic changes, Patient death
Intervention groups
In the intervention group, patients receive nursing services in addition to routine care. The intervention group will be visited daily by the nurse for 3 days daily for 3 days. The general patient care provided to him in the ICU will be addressed to the patient nurse and he will be trained on all the patient's care needs in theward. In the control group, routine care involves informing the patient about the transfer to the department and its discharge by coordination.
Main outcome variables
Family satisfaction, physiological indices

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160110025929N12
Registration date: 2018-05-16, 1397/02/26
Registration timing: registered_while_recruiting

Last update: 2018-05-16, 1397/02/26
Update count: 0
Registration date
2018-05-16, 1397/02/26
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
2018-03-21, 1397/01/01
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impacts of liaison nurse role on family satisfaction and physiological parameters of discharging patients in the intensive care unit
Public title
Impacts of liaison nurse role on family satisfaction and physiological parameters ofpatients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age of patients between (18-65) years Patients admitted to the intensive care unit who have been admitted for at least 72 hours. According to the doctor's order, the patient able to transferred from the intensive care unit to the general ward
Exclusion criteria:
Sudden hemodynamic changes Patient death
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Actual sample size reached: 90
Randomization (investigator's opinion)
Randomized
Randomization description
90 patients will be selected as available. Then they will be randomly divided into two groups of intervention and control using the random numbers table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2017-08-30, 1396/06/08
Ethics committee reference number
IR.UMSHA.REC.1396.411

Health conditions studied

1

Description of health condition studied
Head truama
ICD-10 code
S06
ICD-10 code description
Intracranial injury

Primary outcomes

1

Description
Family satisfaction
Timepoint
Before and after intervention
Method of measurement
Questionnaire

2

Description
Physiological Indices
Timepoint
Before and after intervention
Method of measurement
Check list

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, patients receive nursing services in addition to routine care. The intervention group will be visited daily by the nurse for 3 days daily for 3 days. The general patient care provided to him in the ICU will be addressed to the patient nurse and he will be trained on all the patient's care needs in theward.
Category
Other

2

Description
Control group: In the control group, routine care involves informing the patient about the transfer to the department and its discharge by coordination.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Mahnaz Khatiban
Street address
Besat St, Besat hospital, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
khatiban@umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s-bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahnaz Khatiban
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
khatiban@umsha.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ensieh Elyasi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
Ensiyeh.elyasi1984@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mehdi Molavi
Position
instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
m.molavi@umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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